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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027072
Receipt No. R000028112
Scientific Title Clinical usefulness of instantaneous wave-free ratio for evaluation of coronary artery lesion with prior myocardial infarction
Date of disclosure of the study information 2017/04/21
Last modified on 2019/04/22

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Basic information
Public title Clinical usefulness of instantaneous wave-free ratio for evaluation of coronary artery lesion with prior myocardial infarction
Acronym iFR-OMI
Scientific Title Clinical usefulness of instantaneous wave-free ratio for evaluation of coronary artery lesion with prior myocardial infarction
Scientific Title:Acronym iFR-OMI
Region
Japan

Condition
Condition ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the clinical usefulness of iFR in coronary artery lesions with prior myocardial infarction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The optimal iFR cut-off against the clinical FFR cut-off of 0.80 in coronary artery lesions with prior myocardial infarction
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with stable angina pectoris performed diagnostic coronary angiogram and physiological assessment with iFR and FFR
Key exclusion criteria 1) previous coronary bypass grafting
2) hemodialysis
3) lesion of pMI without myocardial viability assessed with echocardiogramphy or cardiac magnetic resonance imaging (MRI)
4) clinical history of MI with non-target legion
5) chronic total lesion
6) tandem lesion; a major native coronary artery with >=2 stenoses separated by a more normal segment.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Tairo
Middle name
Last name Kurita
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code 514-8507
Address 2-174 Edobashi, Tsu 514-8507, Japan
TEL 059-231-5021
Email k_siho_yuu@hotmail.com

Public contact
Name of contact person
1st name Fukuoka
Middle name
Last name Shusuke
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code 514-8507
Address 2-174 Edobashi, Tsu 514-8507, Japan
TEL 059-231-5021
Homepage URL
Email nrh27260@yahoo.co.jp

Sponsor
Institute Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mie University Graduate School of Medicine Ethics comittee
Address 2-174 Edobashi, Tsu 514-8507, Japan
Tel 059-232-1111
Email s-kenkyu3@mo.medic.mie-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 10 Day
Last follow-up date
2018 Year 10 Month 04 Day
Date of closure to data entry
2018 Year 10 Month 05 Day
Date trial data considered complete
2018 Year 10 Month 31 Day
Date analysis concluded
2019 Year 01 Month 10 Day

Other
Other related information no special instruction

Management information
Registered date
2017 Year 04 Month 20 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028112

Research Plan
Registered date File name
2019/04/21 研究計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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